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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04424381
Other study ID # QL-YK4-012-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 4, 2019
Est. completion date September 20, 2019

Study information

Verified date June 2020
Source The Affiliated Hospital of Qingdao University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.


Description:

Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date September 20, 2019
Est. primary completion date September 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy male or female aged 18 and above.

- The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.

- The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.

- The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects

- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

- Being allergy to the study medications, smoking, alcohol abuse.

- Participation in another clinical trial within 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban 20 MG Oral Tablet [Xarelto]
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].
Rivaroxaban 20 MG Oral Tablet
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.

Locations

Country Name City State
China Phase I Clinical Research Center Qingdao Shandong

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax) 94 days
Primary Area under the plasma concentration versus time curve (AUC)0-t Evaluation of Area under the plasma concentration versus time curve (AUC)0-t 94 days
Primary Area under the plasma concentration versus time curve (AUC)0-8 Evaluation of Area under the plasma concentration versus time curve (AUC)0-8 94 days
Secondary Incidence of Treatment-Emergent Adverse Events Collection of adverse events 94 days
Secondary Incidence of abnormal blood pressure Monitor the blood pressure 94 days
Secondary Incidence of abnormal temperature Monitor the temperature 94 days
Secondary Incidence of abnormal pulse Monitor the pulse 94 days
Secondary Incidence of abnormal electrocardiogram waveform Electrocardiogram inspection 94 days
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